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The powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger or finger to prevent contamination between patient and examiner.

The proposed device is Powder-Free Latex Examination Gloves. The gloves are single use and are provided non-sterile. The proposed device is made of natural rubber latex and meet all the current specifications listed under the ASTM Specification D3578-19, Standard Specification for Rubber Examination Gloves. The proposed device is provided with natural color. The device is available in two lengths, each with six sizes, extra-small (XS), small (S), medium (M), large (L) and extra-large (XL), and extra extra-large (XXL). The device is non-sterile.

The provided document is a 510(k) premarket notification for Powder-Free Latex Examination Gloves. This type of device is classified as a Class I medical device (21 CFR 880.6250 - Non-Powdered Patient Examination Glove).

The information requested regarding acceptance criteria and a study proving the device meets those criteria typically applies to more complex devices, especially those involving AI/ML components or requiring clinical performance studies to establish safety and effectiveness.

For this specific device (examination gloves), the "study" that proves it meets acceptance criteria is primarily non-clinical testing against established ASTM and ISO standards for physical properties, integrity, and biocompatibility. Clinical studies are explicitly stated as not included in this submission.

Therefore, many of the requested points are not applicable in the context of this 510(k) submission for examination gloves. I will address the applicable points and explicitly state where information is not present or not relevant to this type of device.

Acceptance Criteria and Device Performance for Powder-Free Latex Examination Gloves (K222612)

For this device, the "acceptance criteria" are defined by compliance with recognized consensus standards (ASTM and ISO). The "study" proving acceptance is the non-clinical testing performed against these standards.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• The document does not explicitly state the sample sizes (e.g., number of gloves) used for each specific non-clinical test. These sample sizes would be specified within the methodologies of the referenced ASTM and ISO standards.
• Data Provenance: The testing was conducted by or on behalf of Guangdong Kingfa Sci.&Tech. Co., Ltd., based in China. The data is from non-clinical laboratory testing, not human subjects, and is inherently retrospective as it was conducted prior to this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

• Not applicable. For this type of device, "ground truth" is established by the physical and chemical properties measured against the objective metrics defined in the ASTM and ISO standards, using calibrated equipment and standard laboratory procedures. It does not involve human expert interpretation or consensus comparable to image-based medical device studies.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. Adjudication methods are relevant for human-interpretable data where multiple readers might have differing opinions (e.g., medical image interpretation). This submission relies on objective laboratory test results.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. MRMC studies are used for evaluating human performance, typically involving AI assistance in diagnostic tasks. This device is an examination glove, not an AI-enabled diagnostic tool. No clinical study was performed.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not applicable. This device does not have an "algorithm" or standalone AI component. Its performance is measured directly through physical and chemical testing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• The "ground truth" for this device is based on objective measurements against established engineering and biocompatibility standards. For example, tensile strength measured in MPa, hole detection based on water leak AQL, residual powder in mg/glove, protein content in µg/dm², and ISO 10993 series for biological responses (irritation, sensitization, systemic toxicity) are the "ground truth" metrics.

8. The sample size for the training set:

• Not applicable. This is a physical product, not a machine learning model, so there is no "training set."

9. How the ground truth for the training set was established:

• Not applicable due to the absence of a training set.

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